Chemical analyses

Routine testing

Farmalyse performs the following tests routinely on a large scale basis for pharmaceutical products in compliance with GMP-GCLP.

Test package

Acid value
Assay and/or purity HPLC / GC
Assay HPLC or GC
Assay nitrogen Kjelldal
Assay potentiometric titration
Assay spectrophotometry (UV & visible)
Assay titration
Assay volatile (etheric) oils
Average weight & weight-distribution
Coloration and clarity of liquids
Content uniformity HPLC
Content uniformity UV
Density (absolute / relative)
Disintegration time
Dissolution profile (n=12 tablets / capsules)
Dissolution profile (n=6 tablets / capsules)

Dissolution test (1 time point)
Friability of tablets
Hardness / resistance to crushing
Heavy metals
Hydroxyl value
Identity colour reaction
Identity DLC
Identity IR
Identity UV
Iodine value
Limit test ions (contamination)
Loss on drying
Melting point - traject
Metal scan ICP Cd;Pb;Ca;Hg;Ni; Ag;Pd; Na;Ca;K AAS
Neutralisation capacity
Non-saponificational content
Optical rotation

Osmolality
Particle size (stand-alone analyses - microscope)
Particle size (stand-alone analyses)
Particle size as part of total analyses
Peroxide value
pH
Purity DLC / UV
Purity HPLC or GC
Purity HPLC/DAD
Refractive index
Residual solvents
Residue on evaporation
Saponification value
Sulphated ash
Viscosity; rotation
Viscosity; ubbelohde
Water (Karl Fischer)

Special test package

Special test package

Test on polymer and glass containers according to USP and Ph.Eur. 3.1 and 3.2.
Test on impurities in crospovidone (HPLC acc. PhEur.)
Tween 80 in PMMA (UV/VIS spectroscopy)
Monomer acrylates in polymers (GC)
Gentamicine sulphate in medical devices (UPLC)
Nitrogen/Protein by Kjelldahl destruction
Cannabinoids in Cannabis (by UPLC)

Equipment highlights

Equipment highlights

HPLC 10 systems with UV, refractive index and DAD detection
UPLC 1 system with UV, DAD detection
GC-FID system dedicated for direct liquid injections
GC-FID head space system for gas injections
Automated Dissolution measurement by UV/VIS spectroscopy

Validation & method development

Validation studies are carried out according to international guidelines. Farmalyse uses standard validation packages in conformity with ICH guidance. The reports presented have been accepted by many regulatory authorities.
Extensive experience allows the quick design of analytical methods. Method development and subsequent reports are implemented based on GCLP making use of a clear and structured process for each project.

A validation project comprises a study plan, study design, performance of analytical work and subsequent data handling. All data is presented in a detailed study report. Validation studies are performed by dedicated staff with special training on study handling, in accordance with international guidelines  (e.g. PhEur, USP, ICH).

Stability studies

Stability studies are performed in temperature/humidity controlled and monitored cabinets in compliance with ICH or ASTM guidelines.
Standard chamber conditions include:
25°C ± 2°C / 60% RH ± 5%
30°C ± 2°C / 65% RH ± 5%
40°C ± 2°C / 75% RH ± 5%

> CompuBase